Inactivated vaccine is a biological agent that physically and chemically kills pathogenic microorganisms but retains its immunogenicity (that is, the ability to recognize and bind T and B cells and activate them). The inactivated vaccine is a "viral analog" that is not infectious but has the ability to stimulate immunity. Live attenuated vaccine is refers to the artificial method to promote normal bacteria or virus mutation, lost pathogenic but retain the immunogenicity, reproduction ability, live attenuated vaccine in the human body has a certain degree of reproduction or replication, similar to a light natural infection process, but will not lead to human disease.
Inactivated vaccine refers to the "dead virus" prepared by growing the virus in batches on a large scale and treating it with the inactivating agent. As a very classic form of inactivated virus vaccine, human beings are more familiar with it, with more technical experience and more stable production process, which also means that safety is more controllable. And among the vaccines for other diseases on the market, inactivated vaccines, such as rabies inactivated vaccine, influenza inactivated vaccine, hepatitis A inactivated hepatitis vaccine, etc. Inactivated vaccines are also easy to study and prepare quickly, and usually in the event of viral infectious diseases, inactivated vaccines against the virus are often preferred.
At present, the combination of suspension culture and microcarrier technology has become the mainstream way of vaccine production. Process for the bioreactor: Cell growth and virus expansion need to be done in the bioreactor, so the stirring speed, dissolved oxygen (DO), pH, and nutrients (glucose, glutamine, amino acids, etc.) can affect the production of the virus. Therefore, in the early stage of mass production, vaccine manufacturers need to develop processes from the laboratory, determine process operations and parameters, and then gradually expand the scale (usually 3-20L fermentation) to produce vaccines for clinical phase I use. In pilot production (up to 200L), the key process operations and parameters were determined and studied using the experimental design (DOE). The vaccine production process will be verified before phase I clinical trials (up to 2000 L). In order to meet the needs of vaccine research and development and gene therapy, CEKG has launched a series of bioreactors such as SKC300 and SKC600, which can customize the bioreactors according to the needs of customers and help vaccine manufacturers perfectly realize the cultivation process needs.
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